Biotech Values

[DewDiligence]

SNY is plainly mischaracterizing the FDA’s review of NVS/MNTA’s Lovenox ANDA, IMO.

Whereas SNY argues that the FDA’s Nov 2007 request for in vitro immunogenicity data on NVS/MNTA’s drug was effectively a request for data on safety and efficacy, I would assert that it was no such thing. Rather, I would characterize the FDA’s request for in vitro immunogenicity data as a way to verify the manufacturing purity of NVS/MNTA’s drug.

Verification of manufacturing purity is a regular feature of generic-drug applications, and hence there was no variance from the governing statues as SNY alleges.